Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K063493 |
Device Name |
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 |
Applicant |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538 -6515
|
|
Applicant Contact |
CHRISTINE DUNBAR |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538 -6515
|
|
Correspondent Contact |
CHRISTINE DUNBAR |
Regulation Number | 892.1550
|
Classification Product Code |
|
Date Received | 11/20/2006 |
Decision Date | 12/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|